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ROI CalculatorKey Quality Attributes formerly known as Critical Quality Attributes are defined by regulated industries (e.g., pharmaceuticals and medical devices) as biological, chemical, physical, or microbiological aspects of a product that have to be strictly monitored to ensure product safety, effectiveness, and performance.
A solid understanding of quality management and the CQA lifecycle forms the backbone of a successful QMS:
Understanding CQAs entails looking at them through the lens of Quality by Design (QbD):
QTPP (Quality Target Product Profile): Key Quality Attributes help ensure that you know how your drug or device will comply with your prospective summary of the drug or device's quality.
CQA (Critical Quality Attribute): The specific physical/chemical characteristics (e.g., pH, sterility, purity, dissolution rate) of the product that must be monitored to meet the defined Key Quality Attributes.
CPP (Critical Process Parameter): The manufacturing variables (e.g., temperature, mixing speed) that directly relate to and define the Critical Quality Attribute.
For compliance with standards like ICH Q10, managing CQAs within your QMS requires specific, ongoing processes:
Risk Assessment: Identifying which aspects of your product are "critical" to the customer's use of the product and how the process may produce non-conforming product, through Quality Risk Management.
Process Performance & Monitoring: Maintaining ongoing "control" of the manufacturing processes by monitoring Key Quality Attributes so that any deviation from specified requirements is detected before it becomes a defect.
Change Management: Formal risk assessments for any changes to the facilities, equipment, or raw materials to determine whether any new risks are created and thus affect the previously defined Critical Quality Attributes.
Although the term "CQA" is primarily used in the pharmaceutical industry, the medical device and equipment manufacturer industry will often refer to it as Key Product Characteristics (KPCs). KPCs include mechanical dimensions, biocompatibility, and software reliability, all of which are critical elements for the safety, compliance, and functionality of a product. Like CQAs, KPCs require enhanced control, systematic monitoring, and rigorous documentation to demonstrate compliance with both ISO 13485 and the FDA's Quality Management System Regulation (QMSR)
A mature quality management system (QMS) is one that does not just respond to failure but rather understands and improves its processes proactively. To ensure that product and process requirements remain in alignment, the Quality Attribute Requirement traceability matrix is often used. It contains a detailed mapping of every validated critical process parameter (CPP) to its corresponding critical quality attribute (CQA).
